Therapeutic Solutions International Prepares to Apply for Emergency Use Authorization (EUA) for its FDA Phase III COVID-19 Stem Cell Therapy JadiCell™

Rhea-AI Summary

Therapeutic Solutions International (OTC: TSOI) has initiated preparations for an Emergency Use Authorization (EUA) to the FDA for its JadiCells™ therapy aimed at treating lung injuries related to COVID-19. The EUA enables the use of unapproved medical products during public health emergencies. The company reports promising preclinical data and recently received FDA clearance for a Phase III trial, where JadiCells™ showed 100% efficacy in saving lives of COVID-19 ICU patients below 85. Experts from its advisory board are facilitating fast-track approval processes.

Positive

• Initiated preparations for Emergency Use Authorization for JadiCells™.
• Received FDA clearance for Phase III trial for JadiCells™.
• Demonstrated 100% efficacy in previous trials for patients under 85.

Negative

• None.

ELK CITY, Idaho, Aug. 16, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today initiation of preparation for filing an Emergency Use Authorization (EUA) to the FDA for JadiCells™ in treatment of COVID-19 associated lung injury. 

The EUA is a mechanism that allows FDA to help strengthen the nation's public health protections against threats such as infectious diseases by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies. Under this provision, the FDA may authorize unapproved medical products to be used in an emergency to treat serious or life-threatening diseases or conditions.

"The extremely promising preclinical data we are generating, as well as the previously published double blind FDA clinical trial and most recently, FDA clearance to enter Phase III, strongly supports the rationale to file for Emergency Use Authorization" said Dr. James Veltmeyer, Chief Medical Officer of the Company. "As a practicing physician, myself and my colleagues are eager to begin using these cells and potentially saving lives".

In previous studies the Company has demonstrated the superior activity of JadiCell™ to other types of stem cells including bone marrow, adipose, cord blood, and placenta. Furthermore, in an FDA double blind clinical trial the JadiCell™ was shown to be 100% effective in saving the lives of COVID-19 ICU patients¹ under the age of 85. On August 5^th, 2021, the FDA granted clearance for initiation of a Phase III pivotal trial using JadiCells to treat COVID-19².

"We are thankful to our Advisory Board, which includes Dr. Francesco Marincola, World Wide Head of Cell Therapy Research for Gilead, and Dr. Santosh Kesari, Principle Investigator on other stem cell trials for COVID-19, for bringing decades of national and international expertise in dealing with regulatory bodies in fast-tracking approval of cellular and gene therapies in helping us to make this monumental decision" said Timothy Dixon, President and CEO of Therapeutic Solutions International. "Given the urgent nature of the ongoing pandemic, and the early suggestions that our cells are effective against the delta variant, we are exploring and pursuing all possible avenues to bring JadiCells to the patients that need them now."

About Therapeutic Solutions International, Inc.
Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/ 

1 Umbilical cord mesenchymal stem cells for COVID–19 acute respiratory distress syndrome: A double–blind, phase 1/2a, randomized controlled trial - Lanzoni - 2021 - STEM CELLS Translational Medicine - Wiley Online Library

2 Therapeutic Solutions International Receives FDA Clearance to Initiate Phase III Pivotal Registration Trial for JadiCell™ Universal Donor COVID-19 Therapy (prnewswire.com)

Contact:
ir@tsoimail.com

 

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SOURCE Therapeutic Solutions International

FAQ

What is the purpose of the Emergency Use Authorization for JadiCells™ by Therapeutic Solutions International (TSOI)?

The EUA allows unapproved products to be used in emergencies, enabling the use of JadiCells™ for treating COVID-19 associated lung injuries.

When did Therapeutic Solutions International (TSOI) receive FDA clearance for the Phase III trial of JadiCells™?

The FDA granted clearance for the Phase III trial on August 5, 2021.

What results did JadiCells™ show in previous trials for COVID-19 patients?

JadiCells™ were shown to be 100% effective in saving the lives of COVID-19 ICU patients under the age of 85.

What is the significance of the Phase III trial for JadiCells™ by Therapeutic Solutions International (TSOI)?

The Phase III trial is critical for validating the efficacy and safety of JadiCells™ in treating COVID-19, potentially leading to full FDA approval.

Who are the key experts involved in the EUA process for JadiCells™ at Therapeutic Solutions International (TSOI)?

The advisory board includes notable experts like Dr. Francesco Marincola and Dr. Santosh Kesari, who have extensive experience in regulatory processes.